TheraRadar
Data updated: May 26, 2026

AXITINIB

Oncology Approved 2025-10-30
Jump to: Indications Approvals Trials Competitors Safety Patents
1
Indication
--
Phase 3 Trials
0
Years on Market

Details

Status
Discontinued
First Approved
2025-10-30
Routes
ORAL
Dosage Forms
TABLET

Companies

Apotex Teva Novartis
Active Ingredient: AXITINIB

AXITINIB Approval History

2026
Original
New Indication
New Form
Label Update
2 FDA actions from 2025 to 2025
Oct 2025 ORIGINAL
Update
FDA Letter

What AXITINIB Treats

1 FDA approvals

Originally approved for its first indication in 2025 .

  • Other (1)
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Clinical Trial Registry

99 trials
Trial Sponsor ID Phase Status Title
NCT05805501 BO43936 Ph 2 active not recruiting A Study of Immune Checkpoint Inhibitor Combinations With Axitinib in Participants With Untreated Locally Advanced Unresectable or Metastatic Renal Cell Carcinoma
NCT02535533 results posted 201507716 Ph 1, Ph 2 completed SLM + Axitinib for Clear Cell RCC
NCT05327686 SAMURAI NRG-GU012 NCI-2022-02189, NRG-GU012 Ph 2 recruiting Testing the Addition of Stereotactic Radiation Therapy With Immune Therapy for the Treatment of Patients With Unresectable or Metastatic Renal Cell Cancer, SAMURAI Trial
NCT01744249 results posted AXI-IIG-02 2011-001550-29 Ph 2, Ph 3 completed Sandostatin LAR and Axitinib vs Pbo in Pnts With Advanced Well-differentiated Non-pancreatic Neuroendocrine Carcinomas
NCT04355156 AXMUS-C results posted WS913975 2011-002598-49 Ph 2 completed Axitinib Monotherapy With Early Dynamic Contrast Enhanced Ultrasound Monitoring in Chemorefractory Third Line Metastatic Colorectal Cancer
NCT05059522 B9991046 2023-509466-38-00 Ph 3 active not recruiting Continued Access Study for Participants Deriving Benefit in Pfizer-Sponsored Avelumab Parent Studies That Are Closing
NCT05969496 NEOPAX 22-1669.cc Ph 2 recruiting Neoadjuvant Pembrolizumab and Axitinib in Renal Cell Carcinoma With Inferior Vena Cava Tumor Thrombus
NCT05808608 AK104AXI-ssRCC Ph 1, Ph 2 active not recruiting A Study of AK104 Plus Axitinib in Advanced/Metastatic Special Pathological Subtypes of Renal Cell Carcinoma
NCT03297606 CAPTUR PM1 ESR-17-12831, CA209-9DL Ph 2 recruiting Canadian Profiling and Targeted Agent Utilization Trial (CAPTUR)
NCT05017012 3475A-C18 MK-3475A-C18, jRCT2031220507 Ph 1 active not recruiting A Study to Evaluate the Bioavailability of Pembrolizumab (MK-3475) Via Subcutaneous (SC) Injection of Pembrolizumab Formulated With Berahyaluronidase Alfa (MK-5180) [MK-3475A] In Advanced Solid Tumors (MK-3475A-C18)
NCT07123090 SPARCC 25-258 Ph 2 recruiting A Study of Sasanlimab, Palbociclib and Axitinib in Metastatic Renal Cell Carcinoma
NCT07469683 4-2024-1664 Ph 2 recruiting An Open-label, Randomized Phase 2 Clinical Trial to Evaluate the Efficacy and Safety of the Combination Therapy of SLC-3010 and Axitinib Compared to Axitinib Monotherapy as a Second-line Treatment for Locally Advanced or Metastatic Clear Cell Renal Cell Carcinoma
NCT04693468 2020-0436 NCI-2020-06041, 2020-0436 Ph 1 recruiting Talazoparib and Palbociclib, Axitinib, or Crizotinib for the Treatment of Advanced or Metastatic Solid Tumors, TalaCom Trial
NCT06860386 MCC-23473 Ph 2 suspended Study of Adaptive Immunotherapy With VEGFR-TKI in Patients With Advanced RCC
NCT01409200 2011-0231 NCI-2015-01711, NCI-2011-02749 Ph 2 completed Antiandrogen Therapy With or Without Axitinib Before Surgery in Treating Patients With Previously Untreated Prostate Cancer With Known or Suspected Lymph Node Metastasis
NCT03839498 AAAR5314 Ph 2 active not recruiting Study of Axitinib (AG-013736) With Evaluation of the VEGF-pathway in Pheochromocytoma/Paraganglioma
NCT05384496 22-017 Ph 2 recruiting Axitinib and Nivolumab for the Treatment of Mucosal Melanoma
NCT07383441 S2419 NCI-2026-00080, S2419 Ph 3 not yet recruiting Adding Biotherapy or Placebo to Standard Treatment for Advanced Kidney Cancer
NCT02853331 results posted 3475-426 163460, MK-3475-426 Ph 3 completed Study to Evaluate the Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Axitinib Versus Sunitinib Monotherapy in Participants With Renal Cell Carcinoma (MK-3475-426/KEYNOTE-426)
NCT04585815 results posted B8011011 2020-002829-28 Ph 1, Ph 2 terminated Study of Immunotherapy (Sasanlimab) in Combination With Targeted Therapies in People With Advanced Non-small Cell Lung Cancer (NSCLC) (Landscape 1011 Study)
NCT03092856 4K-16-5 NCI-2017-00223, 4K-16-5 Ph 2 active not recruiting Axitinib With or Without Anti-OX40 Antibody PF-04518600 in Treating Patients With Metastatic Kidney Cancer
NCT05363631 202104398 Ph 1, Ph 2 active not recruiting Seleno-L Methionine (SLM)-Axitinib-Pembrolizumab
NCT04996823 MCC-21112 63403991 Ph 2 recruiting Axitinib + Ipilimumab in Advanced Melanoma
NCT03595124 results posted NCI-2018-01489 NCI-2018-01489, AREN1721 Ph 2 active not recruiting A Study to Compare Treatments for a Type of Kidney Cancer Called TFE/Translocation Renal Cell Carcinoma (tRCC)
NCT06962787 BL-B01D1-204-13 Ph 2 recruiting A Study of BL-B01D1+TKI±Pembrolizumab in Patients With Locally Advanced or Metastatic Renal Cancer
NCT03172754 GU-102 17-1009 Ph 1, Ph 2 active not recruiting Study of Nivolumab and Axitinib in Patients With Advanced Renal Cell Carcinoma
NCT04258956 AXAGIST AXAGIST Ph 2 completed A Study of Avelumab In Combination With Axitinib in Patients With Unresectable/Metastatic Gastrointestinal Stromal Tumor After Failure of Standard Therapy
NCT04458259 C4201002 2021-004270-59, ARRAY-067-102 Ph 1 terminated Study of PF-07265807 in Participants With Metastatic Solid Tumors.
NCT05949632 INCB99280-201 2023-510281-27-00, 2022-003663-13 Ph 1, Ph 2 terminated A Study of INCB099280 in Combination With Axitinib in Adults With Advanced Solid Tumors
NCT04341181 ProTarget ProTarget Ph 2 recruiting ProTarget - A Danish Nationwide Clinical Trial on Targeted Cancer Treatment Based on Genomic Profiling
NCT04522323 D7980C00003 2023-509604-15-00, 2019-004338-41 Ph 1 active not recruiting A Study to Evaluate MEDI5752 and Axitinib in Subjects With Advanced Renal Cell Carcinoma
NCT06161558 10001657 001657-C Ph 1 withdrawn Erlotinib in Combination With Select Tyrosine Kinase Inhibitors in Adult Patients With Advanced Solid Tumors
NCT04493203 results posted HCC 20-101 Ph 2 completed Nivolumab Plus Axitinib in Patients With Anti-PD1 Refractory Advanced Melanoma
NCT02912572 results posted 16-322 Ph 2 active not recruiting Avelumab in Patients With MSS, MSI-H and POLE-mutated Recurrent or Persistent Endometrial Cancer and of Avelumab/Talazoparib and Avelumab/Axitinib in Patients With MSS Recurrent or Persistent Endometrial Cancer
NCT04337970 20-001 Ph 1, Ph 2 completed Talazoparib and Axitinib for People With Previously Treated Advanced Kidney Cancer
NCT02597322 AXIPAN P110209 Ph 2 completed Study of Axitinib for Downstaging Large Renal Tumors Not Primarily Suitable for Partial Nephrectomy (AXIPAN)
NCT05256472 AK104-213 Ph 2 active not recruiting A Study of AK104 Monotherapy or AK104 Plus Axitinib in Advanced/Metastatic Renal Cell Carcinoma
NCT06364631 CARE1 2023-503317-29-00 2023/3764 Ph 3 recruiting CARE1 Pragmatic Clinical Trial
NCT04562441 NPC 033 Ph 2 completed NPC - AXEL Study : Axitinib-Avelumab
NCT05097599 StrataPATH STR-004-001 KEYNOTE-F04 Ph 2 terminated StrataPATH™ (Precision Indications for Approved Therapies)
NCT05904730 A6334536 Ph 1 completed Phase I Clinical Trials Investigating the Potential Efficacy of Axitinib in Patients With a BRCA 1/2 Mutations
NCT06211114 FD-001-II-RCC Ph 2 recruiting Study to Evaluate the Efficacy and Safety of Immunotherapy With Axitinib in Advanced Collecting Duct Carcinoma
NCT01693822 A-PREDICT results posted ICR-CTSU/2011/10033 Ph 2 completed A Phase II Study of Axitinib in Patients With Metastatic Renal Cell Cancer Unsuitable for Nephrectomy
NCT02639182 results posted AGS-16C3F-15-3 Ph 2 completed A Study of AGS-16C3F vs. Axitinib in Metastatic Renal Cell Carcinoma
NCT06690697 2411091-1 Ph 2 recruiting Combination of Toripalimab and JS004 Therapy for ccRCC
NCT03990571 results posted 2019-0107 NCI-2019-03704, 2019-0107 Ph 2 completed Axitinib and Avelumab in Treating Patients With Recurrent or Metastatic Adenoid Cystic Carcinoma
NCT02667886 results posted X4P-001-RCCA Ph 1, Ph 2 completed Trial of X4P-001 in Participants With Advanced Renal Cell Carcinoma
NCT01263769 results posted 2010-0072 NCI-2011-00279 Ph 2 completed Neoadjuvant Axitinib in Locally Advanced Renal Cell Carcinoma (RCC)
NCT02636725 results posted 20150932 Ph 2 completed Axitinib and Pembrolizumab in Subjects With Advanced Alveolar Soft Part Sarcoma and Other Soft Tissue Sarcomas
NCT02859012 AxitinibACC Axitinib in ACC Ph 2 completed Study of Axitinib in Patients With Recurred or Metastatic Adenoid Cystic Carcinoma

Showing 50 of 99 trials

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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

AXITINIB FDA Label Details

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INLYTA

Full clinical data, patents, trials, and competitive landscape for axitinib.

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Data Sources

FDA Approval: ANDA211650 → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.